Kornimate/medical-research-clean huggingface dataset:
how to optimize enteral feeding of the full enteral feeding preterm infant

Conditions: Preterm Birth; Feeding Methods

Summary: very low-birth-weight premature infants (vlbws) are fed via nasal or oro-gastric tube for a long time because of the physiological inability to coordinate swallowing, sucking, and breathing until at least 34 weeks of gestational age. both bolus and continuous feeding modes are widely described in the literature; both modes have specific risks and benefits, and there is no evidence in the literature as to which mode is best in terms of tolerance and adverse effects. to date, the characteristics of enteral feeding that are associated with better feeding tolerance and fewer adverse effects have not been uniquely documented. there are currently no data in the literature directly comparing different modes of enteral feeding tube management in the preterm vlbw infant. therefore, our study aims to evaluate different modes of enteral feeding tube management (extemporaneous vs. permanent introduction/removal and oral vs. nasal introduction route) in order to optimize enteral feeding management of the vlbw infant.

the purpose of the study is to evaluate the tolerance of intermittent gastric tube placement versus permanent gastric tube maintenance in preterm vlbw infants who have achieved full enteral feeding, and to record the incidence of adverse effects associated with the different modes of gastric tube management. specifically, during bolus feeding, the following parameters will be evaluated in association with the two different management modes: 1. presence, extent and characteristics of episodes of gastric stagnation 2. incidence of cardio-respiratory events (desaturation and/or bradycardia) 3. signs and symptoms of pain/discomfort related to the tube insertion and removal procedure in addition, the above parameters will be examined during enteral feeding with an orally or nasally introduced tube.

Eligibility criteria:
inclusion criteria: * gestational age \<32 weeks and/or neonatal weight \<1500 g * achievement of full enteral feeding (150 ml/kg/day of milk) * exclusive feeding of human milk (breast and/or bank) * informed consent signed by parent or legal guardian exclusion criteria: * need for invasive ventilatory support * congenital malformations affecting the gastrointestinal tract

Keywords: enteral feeding preterm newborns full enteral feeding
effects of a genistein concentrated polysaccharide (gcp) for prostate cancer on active surveillance.

Conditions: Prostate Cancer

Summary: genistein combined polysaccharide (gcp) may play a role as a secondary chemopreventive agent in the treatment of localized prostate cancer.


Eligibility criteria:
inclusion criteria: * participants must be male and have a pathological diagnosis of prostate cancer * pathological diagnosis of prostate cancer must be confirmed and on file with cra prior to study entry. * no treatment (surgery, radiation, or hormones) prior to study entry. * psa between 2.0 and 10.0 ng/ml. * if psa is \>10.0, patient must have been on active surveillance for 12 months prior to study initiation. * no known allergy to soy or soy products. * the patient is not currently taking more than 2 grams of genistein a day in nutritional or diet enhancing supplements (otc supplements). * participant has not been on any previous gcp clinical trial. * normal chemistry values prior to study entry. exclusion criteria: * no pathological documentation of prostate cancer. * prior treatment for prostate cancer. * psa \>10.0 ng/ml but not on active surveillance for 12 months. * allergy to soy or soy products. * abnormal chemistry values.

Keywords: localized prostate cancer
comparison of thrice daily biphasic human insulin with basal bolus regimen in type 2 diabetes mellitus patients

Conditions: Diabetes Mellitus, Type 2

Summary: it is a proven fact that basal bolus insulin regimen is the near- physiological regimen \& thrice daily biphasic insulin aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. in this study the investigators evaluated whether biphasic human insulin can be used in a thrice daily regimen in place of biasp. as the regimen is less expensive and one prick less than the basal-bolus regimen, it can be a good alternative for a diabetics in india. this is a 12 week open labelled parallel-randomised controlled pilot study - 50 patients with type 2 diabetes mellitus was selected after satisfying the inclusion and exclusion criteria's .metformin and pioglitazone were continued and they are randomised into 2 groups at base line and was allotted into any of the two regimens. 1. basal detemir + bolus aspart or 2. thrice daily biphasic human insulin regimen. the two regimens were compared by the following variables: primary endpoint: glycaemic control secondary endpoint: weight gain, hypoglycaemic episodes, adverse effects and cost effectiveness

it is a proven fact that basal bolus insulin regimen is the near- physiological regimen \& thrice daily biphasic insulin aspart is a comparable alternative for glycemic control in type 2 diabetes mellitus patients. in this study the investigators evaluated whether biphasic human insulin can be used in a thrice daily regimen in place of biasp.

Eligibility criteria:
inclusion criteria: * type 2 diabetics \>/= 18 yrs of age diabetic for \>/= 6months * inadequately controlled patients treated with human premixed insulin twice daily for at least 3months along with metformin 2g/d and pio30mg/d * single dose of insulin exceeding 25 units or total insulin dose is more than 0.7u/kg/day with * if post lunch blood glucose is not controlled * if hba1c ≥7% * no major cardiac events in the preceding 6 months. * nyha \<= class ii. exclusion criteria: * deranged lft's- ast,alt or alp values \>= 2 times. * deranged rft sr. creatinine \>=1.5 * allergy to insulin or its products. * recent intake of any new medications for sugar control. * illiterate to the level that she/he cannot understand the study. * any other acute co morbid illness. * pregnancy. * decompensated heart failure/usa/mi all within last 12month * untreated proliferative retinopathy/ maculopathy * drug or alcohol dependence

Keywords: type 2 diabetes mellitus biphasic human insulin thrice a day basal bolus insulin
triferic avnu infusion via freedom pump during hemodialysis

Conditions: End Stage Renal Disease

Summary: the main purpose of this study is to evaluate the delivery of triferic avnu intravenously using the freedom pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.

this is a single center, multi dose, open label study assessing the delivery of triferic avnu administered intravenously to adult patients (\> or equal to 18 years of age) using the freedom pump-20 during hemodialysis into the pre-dialyzer and post-dialyzer blood lines.

Eligibility criteria:
inclusion criteria: 1. participant must be 18 years of age inclusive, at the time of signing the informed consent. 2. receiving chronic hemodialysis for 3-4 hours each session 3x/week. 3. medically stable according to the investigator opinion 4. capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria: 1. hemodynamically unstable during hemodialysis 2. evidence of active bleeding from the gi tract.
improving implementation of evidence based ptsd psychotherapy for veterans in the community

Conditions: PTSD

Summary: to further increase the access of evidence based psychotherapies for veterans with posttraumatic stress disorder, we propose to offer training and intensive consultation to community-based providers in cognitive processing therapy for posttraumatic stress disorder. however, we believe that many clinicians may not implement cognitive processing therapy or take advantage of consultation after initial training. for this reason, we propose to examine the effectiveness of an enhanced training method, which would add motivational interviewing to the standard cognitive processing therapy training. motivational interviewing is a form of collaborative discussion for strengthening motivation and commitment to change. we hypothesize that augmenting the standard cognitive processing therapy training with these techniques will reduce providers' reluctance to fully implement the interventions.


Eligibility criteria:
inclusion criteria: * at least 18 years of age * currently licensed in their mental health discipline or a graduate level trainee in their mental health discipline exclusion criteria: * have completed a 2-day training in cognitive processing therapy

Keywords: evidence based psychotherapy implementation ptsd
ozurdex for treatment of recalcitrant diabetic macular edema

Conditions: Diabetic Macular Edema; Non-proliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy

Summary: the purpose of this study is to test the efficacy of an 0.7 mg intravitreal dexamethasone implant (ozurdex®) on macular leakage and visual acuity for patients with recalcitrant diabetic macular edema.

this is an open-label, phase ii comparative study of an intravitreal dexamethasone implant versus intravitreal bevacizumab (avastin) in 20 patients with recalcitrant diabetic macular edema and prior treatment with ≥ 2 intravitreal anti-vegf injections.

Eligibility criteria:
inclusion criteria: * presence of npdr or pdr as confirmed by fluorescein angiography * prior treatment with \>= 2 intravitreal anti-vegf injections but no treatment in last 4 weeks * \ = 2 intravitreal anti-vegf injections * age 18 years or older * etdrs visual acuity between 3 and 78 letters (approximate snellen equivalent of 20/25 to 20/800) * ability to provide written informed consent * capable of complying with study protocol. exclusion criteria: * intraocular injection of steroid medication within prior 3 months * evidence of significant geographic atrophy on fluorescein angiography in the opinion of the treating physician * concurrent ocular disease (wet amd, significant erm, etc) that would limit visual acuity in the opinion of the treating physician * prior vitrectomy surgery * use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or extensive dermal) within 1 month prior to day 1. * known history of iop elevation in response to steroid treatment in either eye that resulted in any of the following: a) = 10 mm hg increase in iop in response to steroid injection, or b) iop = 25 mm hg and required 2 or more anti-glaucoma medications to keep iop below 21 mm hg. * patients who are pregnant. * unwilling or unable to follow or comply with all study related procedures

Keywords: macular edema dme pdr npdr ozurdex dexamethasone avastin bevacizumab
a dose finding study with i.v. panobinostat (lbh589), docetaxel, and prednisone in patients with hormone refractory prostate cancer

Conditions: Prostate Cancer

Summary: this phase ib dose escalation study is designed to characterize the safety, tolerability and preliminary efficacy of i.v. panobinostat (lbh589) in combination with docetaxel and prednisone in the 1st line treatment of patients with hormone refractory prostate cancer.


Eligibility criteria:
inclusion criteria: * hrpc patients * evidence of disease progression * self care, able to perform light work activities * willing to use contraception throughout the study and for 12 weeks after study completion exclusion criteria: * history of other cancers not curatively treated with no evidence of disease for more than 5 years. * prior radiotherapy within 3 weeks of starting study treatment * prior radiopharmaceuticals (strontium, samarium). * impaired cardiac function * heart disease * liver or renal disease with impaired functions. other protocol-defined inclusion/exclusion criteria may apply

Keywords: male prostate cancer hrpc daci
antibiotic treatment versus no therapy in kidney transplant recipients with asymptomatic bacteriuria

Conditions: Asymptomatic Bacteriuria; Pyelonephritis

Summary: objective: to determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.

design: randomized prospective study. setting: university hospital with an active kidney transplantation program. patients: adult kidney transplant recipients. interventions: kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy. measurements: urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. urine culture will be as well collected if urinary symptoms appeared. primary end points: to determine in both groups: the incidence of pyelonephritis. secondary end points: to determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.

Eligibility criteria:
inclusion criteria: * patients who receive a transplant allograft during study period exclusion criteria: * no acceptation of study
the role of the amylin analogue cagrilintide in bone metabolism

Conditions: Obesity

Summary: in this study we will investigate how the medicine cagrilintide affects bone health in women after menopause with obesity during weight loss, compared to treatment with placebo (the dummy medicine with no active substances) and semaglutide. the purpose is to examine whether cagrilintide can reduce the decline in bone mass associated to weight loss. participants will either get cagrilintide, semaglutide, cagrisema (cagrilintide combined with semaglutide), or placebo. which treatment participants get is decided by chance. semaglutide is already approved for the treatment of overweight and obesity and can be prescribed by doctors. cagrilintide and cagrisema are new medications currently under development for weight management. the study will last for about 79 weeks.


Eligibility criteria:
inclusion criteria * female. * post-menopausal at screening (defined as minimum 12 months of amenorrhea, high levels of follicular stimulating hormone (fsh) 16 - 130 international units per liter (iu/l), and low levels of anti-müllerian hormone (amh) and inhibin b). * age 50-70 years (both inclusive) at the time of signing the informed consent. * body mass index (bmi) greater than or equal to \>= 30.0 kilograms per square meter (kg/m\^2). exclusion criteria * previous or current bone disease (e.g., osteoporosis, paget's disease of bone, or bone cancer). * presence of disease affecting bone metabolism (e.g., diabetes mellitus, hyperparathyroidism, hyper or hypothyroidism, chronic kidney disease, celiac disease, or inflammatory diseases (e.g., psoriatic arthritis or ankylosing spondylitis)). * treatment with any medication affecting bone metabolism within 6 months prior to screening as judged by the investigator (e.g., anti-resorptive medication, anabolic medication, systemic hormone replacement therapy (hrt), or systemic corticosteroids).
evaluation of efficacy, safety and tolerability of aldafermin in a phase 2b, randomized, double-blind, placebo-controlled, multi-center study in subjects with nonalcoholic steatohepatitis and stage 2/3 fibrosis (alpine 2/3)

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: this is a multi-center evaluation of ngm282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed nash and f2/f3 fibrosis.


Eligibility criteria:
inclusion criteria: 1. histologically confirmed nash diagnosis as defined by the nash crn 2. total liver fat content of ≥ 8% as measured by mri-pdff exclusion criteria: 1. clinically significant acute or chronic liver disease of an etiology other than nash 2. evidence of drug-induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis 3. history or presence of cirrhosis (compensated or decompensated) as determined by histology and/or relevant medical complications and/or laboratory parameters 4. prior or pending liver transplantation other protocol-defined inclusion/exclusion criteria could apply.
randomized clinical trial to increase physical activity after a a hypertensive pregnancy

Conditions: Hypertension in Pregnancy; Preeclampsia; Gestational Hypertension

Summary: stepup is a 12-week randomized clinical trial among 126 postpartum women with pregnancies complicated by hypertensive disorders. participants will be randomized to a control arm and receive a fitbit or an intervention arm. the intervention arm will receive a fitbit and set a step count goal, receive daily feedback via text about whether they reached their goal, and will be placed in virtual teams with other participants where they can win points for their team if they meet their daily goals. the main study outcomes will be increase in mean step count and change in psychosocial survey measures.

women with hypertensive disorders of pregnancy, such as preeclampsia and gestational hypertension, are at elevated risk of developing hypertension, diabetes, heart failure, and premature atherosclerotic cardiovascular disease. current guidelines recommend intensive lifestyle modification for women with a history of hypertensive disorders in pregnancy in order to reduce the risk of developing cardiometabolic risk factors or overt cv disease. however, limited research exists to guide how to implement lifestyle modification for this population. the postpartum period poses unique challenges to adopting a healthy lifestyle. remote interventions using mobile technology may be particularly effective. social incentives designed using insights from behavioral economics have been demonstrated to motivate health behavior change, such as increasing physical activity. the objective of this study is to use a randomized clinical trial to test the effectiveness of a 12-week team-based, mobile health interventions using wearable devices and social incentives to increase physical activity in the postpartum period.

Eligibility criteria:
inclusion criteria: * delivered a live baby at hup or pah within 4.0-12.6 weeks prior to study enrollment; * diagnosis of chronic hypertension, gestational hypertension, or preeclampsia during most recent pregnancy; * participating in heart safe motherhood (hsm) program; * ability to read and provide informed consent to participate in the study; * has smartphone and email address exclusion criteria: * does not speak english * answers yes to any of the following questions: * are you currently participating in any other physical activity studies? * do you have any medical conditions or other reasons why you could not participate in a 12-week physical activity program? * participants will be excluded after completing the baseline period if their baseline step count is too high (greater than or equal to 10,000 steps per day).
acute glycemic effects of a very low fat diet in type 2 diabetes

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: there is some consensus that high fat diets can contribute to the development of obesity and type 2 diabetes in humans and animals. an increase in dietary fat has been shown to produce obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat in the diet. in humans, there is some evidence that low-fat diets can produce acute improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. in most human studies, however, dietary fat reduction has been accompanied by a reduction in total calorie intake. it is thus not possible to separate the effects of these 2 metabolic changes. the purpose of this study is to gather preliminary information on the effect of a very-low-fat diet on blood metabolism in persons with type 2 diabetes. the design incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat, 15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. the experimental diet conditions are a) continuation of the moderately-high-fat standardization diet, or b) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. outcomes will be measured after the standardization and the experimental periods. the primary outcome variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate (meal) tolerance, insulin secretion and blood lipids. in addition, we will gather descriptive data on the potential acceptability and utility of a very-low-fat diet constructed using the fat substitute, olestra (sucrose polyester). there are no results yet.


Eligibility criteria:
inclusion criteria: * type 2 diabetes, not tightly controlled at present * not using medication (insulin or oral) to control blood sugar * overweight, but generally healthy
sensorimotor training and gait in diabetic polyneuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: diabetic peripheral neuropathy is a common chronic complication of diabetes mellitus which results in high public health costs and has a huge impact on patients' quality of life. it leads to sensory and motor deficits, which often result in mobility-related dysfunction, and alterations in gait characteristics. these alternations in gait performance cause increase in the risk of fall, which has the strongest association with symptoms of depression in patients with diabetes. however, little is known about possible treatment strategies for improving gait ability and reduce risk of fall in patients with diabetic neuropathy. so, the purpose of this study will be to investigate the effect of sensorimotor training on ankle muscle strength, gait and quality of life in patients with diabetic peripheral neuropathy. to determine if there is an effect for sensorimotor training on gait, ankle muscle strength and quality of life in patients with diabetic peripheral neuropathy, the patient will be assessed before and after 6 weeks of treatment by measurement of ankle muscles strength using isokinetic dynamometer, measurement of different spatiotemporal gait parameters using gait trainer instrument , and assessment of quality of life of the patients using hrql questionnaire (sf-36) before and after the treatment sessions.


Eligibility criteria:
inclusion criteria: * patient who have body mass index did not exceed 30 kg/m2. * type ii diabetes mellitus diagnosed for at least 7 years. * able to walk without assistance or assistive device * able to stand on both feet and on one leg * have controlled blood glucose level by the screening by glycated haemoglobin test (9 % \> hba1c \> 6.5 %) . exclusion criteria: the patients will be excluded if they have: * cognitive deficits, severe retinopathy, scares under their feet, hypo or hypertension, any medical conditions that would confound assessment of neuropathy such as malignancy, active/untreated thyroid disease, other neurological or orthopaedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, or severe osteoarthritis), and severe nephropathy that causes edema or needs haemodialysis.